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Clinical Trials (PDQ®)

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer (Cetuximab Closed as of 05/14/10)

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherRTOG-0839
CDR0000654690, NCT00979212

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer. (cetuximab closed as of 05/14/10)

PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer. (cetuximab closed as of 05/14/10)

Further Study Information

OBJECTIVES:

Primary

  • Determine the mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small cell lung cancer. (cetuximab closed as of 05/14/10)

Secondary

  • Assess overall survival of these patients.
  • Evaluate patterns of first failure in these patients.
  • Determine the acute and late adverse events associated with these regimens.
  • Assess surgical morbidities in patients with resectable disease at reassessment.
  • Determine the correlation between pre- and post-treatment biomarkers (including epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival).
  • Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
  • Assess the ability of FDG-PET/CT scan re-staging to predict outcome.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
  • Arm II: Patients receive induction therapy comprising panitumumab IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 8, 15, 22, 29, and 36. Patients also undergo IMRT or 3D-CRT once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. (cetuximab closed as of 05/14/10) In both arms, patients with resectable disease and no disease progression may proceed to surgery (thoracotomy, lobectomy, or pneumonectomy) approximately 4-6 weeks after completion of induction therapy. After surgery, patients proceed to consolidation therapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the following histologies:
  • Adenocarcinoma
  • Adenosquamous
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration
  • Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)
  • N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
  • Maximum nodal diameter cannot exceed 3.0 cm
  • N2 status must be pathologically confirmed to be positive by one of the following methods*:
  • Mediastinoscopy
  • Mediastinotomy (Chamberlain procedure)
  • Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
  • Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
  • Thoracotomy
  • Video-assisted thoracoscopy
  • Transbronchial needle biopsy by Wang technique (TBNA)
  • Fine-needle aspiration under CT guidance NOTE: *PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status
  • Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:
  • Tumor is left sided
  • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
  • Nodes visible in the anterior/posterior (level 5) region on CT scan
  • Distinct primary tumor separate from nodes visible on CT scan
  • Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
  • If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are > 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative
  • Measurable disease as determined by contrast-enhanced CT scan
  • Primary lung tumor distinct from mediastinal lymph nodes
  • Pleural effusion allowed provided one of the following criteria is met:
  • If pleural fluid is present either before or after pre-study mediastinoscopy or exploratory thoracotomy, a thoracentesis must be performed to document that the pleural effusion is cytologically negative
  • If pleural fluid is present on CT scan, but is deemed too small to tap safely under either CT scan or ultrasound guidance, a thoracoscopy should be done, if feasible, to document the absence of pleural metastases and to document that the pleural effusion is cytologically negative
  • No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
  • Creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum albumin > 3.0 g/dL
  • Serum magnesium normal (supplementation allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of treatment
  • Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
  • Diffusion capacity ≥ 50% predicted
  • No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy [ejection fraction < 50%])
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS or known HIV positivity
  • No unintentional weight loss ≥ 5% of body weight within the past 6 months
  • No prior severe infusion reaction to a monoclonal antibody
  • No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer
  • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No prior therapy that specifically and directly targets the EGFR pathway

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Martin J. Edelman, MDPrincipal Investigator

Trial Sites

U.S.A.
California
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Sue S Yom Ph: 877-827-3222
  Stanford
 Stanford Cancer Center
 Billy W Loo Ph: 650-498-7061
  Email: ccto-office@stanford.edu
Colorado
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
Georgia
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 John A Pablo Ph: 800-622-6877
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Ronald McGarry Ph: 859-257-3379
  Louisville
 University of Louisville School of Medicine
 Neal E Dunlap Ph: 866-530-5516
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Mini J Elnaggar Ph: 888-562-4763
Maryland
  Baltimore
 St. Agnes Hospital Cancer Center
 Richard S. Hudes Ph: 410-368-2910
Massachusetts
  Boston
 Boston University Cancer Research Center
 Gregory A Russo Ph: 617-638-8265
Minnesota
  Edina
 Fairview Southdale Hospital
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Paul Sperduto Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Shankar P Giri Ph: 601-815-6700
Missouri
  Saint Louis
 Barnes-Jewish West County Hospital
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Martin J. Edelman Ph: 505-272-6972
New York
  New York
 Beth Israel Medical Center - Petrie Division
 Benjamin P Levy Ph: 212-367-1729
 New York University Medical Center
 Silvia C Formenti Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Jeffrey A. Bogart Ph: 315-464-5476
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Cincinnati
 University of Cincinnati
 Kevin P. Redmond Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Gregory Videtic Ph: 866-223-8100
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Gregory Videtic Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Gettysburg
 Adams Cancer Center
 Amit B. Shah Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Amit B. Shah Ph: 877-441-7957
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Walter J. Scott Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Nathaniel R Evans Ph: 215-955-6084
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
  York
 WellSpan Health
 Amit B. Shah Ph: 877-441-7957
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Shamus R Carr Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Wisconsin
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Elizabeth M. Gore Ph: 414-805-4380
 Veterans Affairs Medical Center - Milwaukee
 Elizabeth M. Gore Ph: 414-805-4380

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00979212
ClinicalTrials.gov processed this data on September 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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